A two-piece garment designed to be worn by healthcare staff to facilitate hygienic conditions typically in areas where surgery is performed. It typically consists of a shirt and pants composed of disposable materials and is intended to provide a barrier to hel
| Company | Devices | Share |
|---|---|---|
| Tronex International, Inc. | 69 | 28% |
| Asp Global, Llc | 45 | 18% |
| Resource Optimization & Innovation, L.L.C. | 27 | 11% |
| O&M Halyard, Inc. | 23 | 9% |
| Dukal Llc | 21 | 9% |
| Mckesson Medical-Surgical Inc. | 14 | 6% |
| Arrow Medsource Group Limited | 12 | 5% |
| Kenpax International Limited | 11 | 4% |
| Cardinal Health 200, Llc | 10 | 4% |
| Dynarex Corporation | 6 | 2% |
| Icp Medical, Llc | 4 | 2% |
| Medical Action Industries Inc. | 2 | 1% |
Company = labeler of record on GUDID. 14 companies in total; top 12 shown. Click headers to sort.
Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.
| Code | Name | Devices |
|---|---|---|
| LYU | Accessory, Surgical Apparel | 178 |
| LYU | ACCESSORY, SURGICAL APPAREL | 54 |
| FXO | SUIT, SURGICAL | 14 |
| FME | Gown, Examination | 12 |
| FXO | Suit, Surgical | 7 |
| OEA | Non-Surgical Isolation Gown | 6 |
Use these as the dimensions to specify in a tender line.
246 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Scrub suit, single-use", from 14 companies. The largest labeler is Tronex International, Inc. with 28% of records.
LYU (Accessory, Surgical Apparel), LYU (ACCESSORY, SURGICAL APPAREL), FXO (SUIT, SURGICAL), FME (Gown, Examination)
No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.
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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.